1. Field of the Invention
Tough organized embolic thrombus found in the vasculature of the human body may evolve from various origins. A trial thrombus that forms and organizes over the course of days or weeks can dislodge and create an acute arterial blockage. Another example would be a patient with peripheral arterial disease with thrombus in various stages of organization. An intervention procedure could dislodge organized thrombotic debris. The challenge with this debris is that it can be large and difficult to remove with currently available interventional tools. Balloons can smash the debris against the vessel wall if it can be located. Alternatively, there is a class of patients with acute peripheral occlusions, which patients are often immediately referred to surgery for an embolectomy procedure (Fogarty balloon) since this is an efficacious means of addressing the occlusion. The purpose of this invention is to make a practical device to enable an interventional alternative to this surgical embolectomy procedure. The present invention used in conjunction with other interventional equipment is capable of removing a tough and organized embolic thrombus in an interventional procedure. The present invention describes an intravascular catheter and procedure used for purposes of removing an organized embolic thrombus. The catheter generally consists of a grasping mechanism, a mesh capture sleeve, a capture/delivery sheath and housings which catheter is used for relative positioning of the grasping mechanism, the mesh capture sleeve, and the capture/delivery sheath. The catheter of the present invention is delivered over a guidewire. Typically, the guidewire would have a distal occlusion balloon for purposes of drawing the embolic material to within the grasping mechanism.
2. Description of the Prior Art
Surgical embolectomy is a viable method of removing a tough embolic thrombus. However, this surgical procedure is more invasive than an interventional procedure. In general, reducing the invasiveness of the procedure reduces the associated complications. With respect to interventional alternatives, the methods can range from infusion catheters which drip fibrinolytics to balloon procedures which compress the debris against the vessel wall to aspiration with large guide catheters. The debris is generally too tough for removal by mechanical thrombectomy catheters. Fibrinolytic infusion is a viable technique but not guaranteed to be successful. In addition, fibrinolytics are associated with adverse complications such as bleeding or hemorrhagic stroke. With respect to compressing the debris with a balloon or stent, this technique includes deficiencies. First, the debris is not always easily found via fluoroscopy. Second, stenting a thrombus does not remove it from the body and just ballooning and compressing the material will not guarantee that the debris would not further embolize distally.